BD (Becton, Dickinson and Company) Associate Director, WW Supplier Quality Assurance (Grenoble/hybrid) in Le Pont-de-Claix, France
Job Description Summary
With innovative pre-fillable syringes, self-injection systems, safety systems and needle technologies, the Pharmaceutical Systems (PS) team offer an extensive selection of solutions designed to protect, package and deliver drug therapies.
Reporting to BDM-PS Quality Operations Director, we are now looking for our WW Supplier Quality Assurance (SQA) Associate Director to be responsible for managing supplier quality for outsourced material used by BDM-PS plants and finished goods directly sent to customers & Services pertaining to BDM-PS Business.
We are looking for an international oriented senior quality profile to work directly with our various WW production sites located in the United States, Mexico, France, Hungary, England, Japan and transversely with our main outsourced suppliers. This role is attached to our site in Pont de Claix (Grenoble area) with hybrid model of office base and remote working knowing that there is flexibility on how to manage the presence on the site.
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The role sets the quality strategy for outsourced goods and activities and assures alignment of tactics to achieve objectives and drives the BD Quality Culture for the area of responsibility. Through outstanding communication, effective problem solving, and active management of ambiguous situations the role ensures product safety and quality throughout the product lifecycle as well as compliance with all relevant global regulations and customer expectations, putting the customer and patient always first.
Main responsibilities will include:
WW SQA Organization:
Accountable for functional excellence, timely delivery, process effectiveness/efficiency, and compliance with supplier quality management outcomes.
Collaborate with the Operations, Procurement, Quality, and R&D Leadership Teams to prioritize.
Work in close relation with Plant QA Directors to best serves Plant needs while supporting global strategies' implementation and empower them.
Manage the highest risk class Suppliers, including the selection, approval, audits, establishment of Quality Contracts, evaluations, organizational change, continuous improvement, Complaints & Crisis Management.
Lead all WW Operations Quality activities for outsourced finished goods under the virtual plant model. Including the establishment of control strategies, Non-Conformance Management, Batch Release, Customer Complaints, Customer Audits & SAP Master Data Management.
Direct & allocate resources to R&D and Operation Projects (New product development, capacity expansion, assurance of supply, change to win, etc.).
Proactively identify and work through brought-up obstacles and/or undesirable trends that may hinder the organization from focusing on and delivering its objectives.
Talent and organizational capabilities' development:
Develop and mentor associates (6 direct reports and an extended team of 30 people in total) for outstanding contributions to the organization. Conduct annual performance management planning activities for all associates.
Ensure SQA organizational model excellence to empower and improve the organization's impact while using organizational leadership skills and network across BDM-PS sites
Support to BD Quality and BDM-PS strategic imperatives:
Participates as an active member of the PS Quality Operations Leadership team.
Brings to bear knowledge and understanding of the environment to develop practical strategies for PS Operations and WW Quality to support business Portfolio and outsourced Operations strategies.
Anticipate and effectively lead through the challenges of change and establish key partner engagement focused on effective solution solutions.
Responsible for implementing, maintaining, and advancing the business quality system as well as stimulating quality culture, strong team approach, and driving continuous improvement.
We are looking for a senior Quality leader with a strong educational background in a technical related field and a proven track record in leading transformational projects in a fast paced international environment.
A professional experience in the quality department of a strong regulatory environment (ideally in the field of medical devices, but open to automotive, electronics, aerospace).
You have a keen eye for business with demonstrating strong big-picture thinking; a proven track record in effectively integrating and balancing long-term opportunities and challenges with day-to-day activities. In this role, you demonstrate the ability to act in a changing environment and interact efficiently with BDM-PS particularly in a crisis situation to address technical issues and deal with them. You are responsible for enabling an inclusive work environment promoting discussions and diversity of ideas. Ensure all associates have opportunities to influence and contribute to decisions to achieve the best outcome.
Other attributes include:
Proficient in English.
Strong analytical skills.
Solid knowledge of regulations of medical devices' environment (including but not limited to ISO13485, 93/42/EEC 21CFR820).
Do you recognize yourself in this challenge? Do not hesitate to apply!
Becton, Dickinson, and Company is an Equal Opportunity Employer. We do not unlawfully discriminate based on race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity, or expression, genetics, disability, or any other protected status.
Primary Work Location
FRA Le Pont-de-Claix Cedex